User input devices for controlling manipulation of guidewires and catheters

ABSTRACT

A robotic surgical system with an input device has two operational modes by which both steerable and non-steerable elongate instruments can be effectively controlled, such as steerable catheters which can move in at least three orthogonal axes and non-steerable guidewires which can move via axial insertion/retraction or axial rotation. The robotic surgical system may include mapping schemes and haptic feedback to enhance the functionality, operation and ease of use of the input device when controlling non-steerable elongate instruments such as guidewires.

FIELD OF INVENTION

The present disclosure generally relates to robotically controlledsurgical systems, and more particularly, to user input devices fordirecting the movement of elongate surgical instruments to performminimally invasive diagnostic and therapeutic procedures.

BACKGROUND

Robotic interventional systems and devices are well suited forperforming minimally invasive medical procedures as opposed toconventional techniques wherein the patient's body cavity is open topermit the surgeon's hands access to internal organs. Advances intechnology have led to significant changes in the field of medicalsurgery such that less invasive surgical procedures, in particular,minimally invasive surgeries (MIS), are increasingly popular. MIS isgenerally defined as surgery that is performed by entering the bodythrough the skin, a body cavity, or an anatomical opening utilizingsmall incisions rather than large, open incisions in the body. With MIS,a patient can experience less operative trauma, reduced hospitalizationtime, less pain and scarring, reduced incidence of complications relatedto surgical trauma, lower costs, and a speedier recovery.

A typical manual MIS procedure includes the use of an elongateinstrument in the form of a guide wire curved at its distal tip so thatthe guide wire can be navigated through tortuous anatomy when theguidewire is manipulated by hand at a proximal end by a physician. Inaddition to linear insertion and retraction, the proximal end can berolled in the fingertips of the physician to translate a rotationalmotion to a distal portion of the guide wire. Simultaneous axialinsertion and axial rotation of the guidewire achieves spiralinginsertion. In addition to the ability to be advanced and rotated to thetarget site, the guidewire is visible in imaging as a result of itsopacity under fluoroscopic imaging. Once the distal end of the guidewireis at the site of the target lesion or vessel segment, another type ofelongate instrument in the form of a catheter may be inserted co-axiallyover the guide wire. The guide wire might then be retracted and removedsuch that the catheter can remain in place providing a delivery devicefor other minimally invasive instruments.

Robotic MIS devices and techniques can reduce the time consumed formanual MIS surgical procedures and be less physically demanding on thephysician, where manual MIS procedures can not only cause operatorfatigue but also excessive exposure to radiation. Medical roboticsmanufacturers have developed user interfaces to remotely and accuratelyperform various robot-assisted surgical procedures such as the controlof catheters and guidewires in vascular procedures. A typical interfaceconfiguration includes a workstation with one or more monitors and oneor more user input devices.

Furthermore, robotic MIS devices and techniques have advanced such thatelongate catheter instruments may be made steerable at the distal tip.The distal tip may also be controlled by selectively operatingtensioning control elements within the catheter instrument, permittingthe distal tip to be steered. Steerable catheters may be moved inmultiple axes including axial insertion/retraction, axial rotation,deflection/articulation (radial bending) and combinations of thesemotions. As opposed to steerable catheters, two types of motion aregenerally associated with non-steerable elongate instruments, i.e.,axial insertion/retraction and axial rotation.

A need exists for an input device that is useful to accurately controlboth steerable and non-steerable elongate instruments. As such, a userinput device for a robotic system that can direct movement whensteerable devices are attached but also can be optimized for use withnon-steerable devices such as guidewires is desirable. Further, roboticinput devices that emulate manual procedures are desirable to achieveprecise control and physician ease of use. Thus, input device operate inan intuitive manner for both steerable and non-steerable elongateinstruments are desirable.

In addition, because the catheter is maneuvered by control motors, acomputer, and the like, the surgeon lacks tactile feedback to get anintuitive sense of the location of the distal end of the catheter. Thusto perform certain desired applications, such as, for example,instinctive driving and driving in a fluoroscopy view or a pre-operativemodel, tactile feedback implemented by haptics to convey information tothe physician is further desirable.

SUMMARY

A robotic surgical system includes at least one instrument driverconfigured to impart axial movement, axial rotation and articulation toan elongate instrument; at least one control computer electricallycoupled to the instrument driver to actuate the instrument driver inresponse to electronic signals; at least one input device having aninput shaft configured for movement in at least three dimensions andelectrically coupled to the control computer to provide electronicsignals to the control computer that corresponds to movement of theinput device; wherein the input device is configured to operate in atleast two operation modes, with one operation mode that permits movementof the input shaft in at least three dimensions and at least a secondoperation mode that limits the movement of the input shaft to twodimensions of movement within a plane.

A robotic surgical system includes at least one control computerelectrically coupled to an input device and configured to provide hapticsignals to the input device; at least one input device operational intwo dimensions of movement and configured to direct movement of anelongate instrument and configured to generate haptic effects inresponse to haptic signals communicated from the control computer;wherein one of the dimensions of movement comprises two operationalzones, said operational zones relate to broad and precise linear motionof the elongate instrument and the haptic effects comprise a detent onthe border between the two zones.

A robotic surgical system includes at least one control computerelectrically coupled to an input device and configured to provide hapticsignals to an input device; at least one input device configured todirect movement of an elongate instrument and configured to generatehaptic effects in response to haptic signals communicated from thecontrol computer; wherein the haptic effect increases resistance againstmovement in the axis correlated to rotational actuation of the elongateinstrument. The haptic effects can be mapped as a corrugated floor.

Other and further exemplary configurations and advantages thereof willbecome apparent from the following detailed description when read inview of the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a robotic surgical system in an exemplary operationroom set up in which apparatus, system and method embodiments may beimplemented.

FIG. 2 illustrates elongate instruments inside the lumen of a vesselinside a body.

FIG. 3 is a block diagram of an overview of a robotic surgical system.

FIG. 4 illustrates a block diagram of the robotic operationalresponsibilities of the components of an exemplary robotic surgicalsystem.

FIG. 5 illustrates an example of an operator workstation of the roboticsurgical system.

FIG. 6 illustrates an example of an instrument driver capable ofimparting three dimensional motion to a steerable elongate instrument.

FIG. 7 illustrates an example of an instrument driver capable ofimparting linear and axial rotation motion to an elongate instrument.

FIG. 8A illustrates a front perspective view of an exemplary inputdevice and a mapping of spherical three dimensional movement.

FIG. 8B illustrates a front perspective view of an exemplary inputdevice and a mapping of a plane for two dimensional movement.

FIG. 9 illustrates an alternate mapping of a plane of movement with aplurality of operational zones.

FIG. 10 illustrates an alternate mapping of haptic resistance mapped toa virtual corrugated floor.

FIG. 11 illustrates an alternative input device for a non-steerableinstrument.

DETAILED DESCRIPTION

Referring now to the discussion that follows and also to the drawings,illustrative approaches are shown in detail. Although the drawingsrepresent some possible approaches, the drawings are not necessarily toscale and certain features may be exaggerated, removed, or partiallysectioned to better illustrate and explain the present disclosure.Further, the descriptions set forth herein are not intended to beexhaustive or otherwise limit or restrict the claims to the preciseforms and configurations shown in the drawings and disclosed in thefollowing detailed description.

Referring to FIG. 1, a robotically controlled surgical system 100 isillustrated in which an apparatus, a system, and/or method may beimplemented according to various exemplary illustrations. In theillustrated example, system 100 includes an operator workstation 110, anelectronics rack 118, and a robotic instrument assembly 102. The roboticinstrument assembly 102 is controllable using a robotic instrumentdriver assembly 104 (generally referred to as “instrument driver”).During use, a patient is positioned on an operating table or surgicalbed 108 (generally referred to as “operating table”) to which roboticinstrument driver 104 is coupled or mounted by a setup joint mountingbrace 106.

A surgeon is seated at operator workstation 110 and can monitor thesurgical procedure, patient vitals, and control elongate surgicalinstruments like a guidewire or catheter using one or more user inputdevices depending upon the surgical procedure. Workstation 110 includesat least one monitor 112, a workstation pendant 114, and at least oneuser input device 116 which can be a multi-directional joystickapparatus. However, it is understood that other multi-directional userinput devices are also contemplated. A monitor 112 may be configured todisplay a three dimensional object, such as an image of a catheterand/or guidewire in a body cavity or organ, e.g., a chamber of apatient's heart. Referring now to FIG. 2, which illustrates an exemplaryimage of a surgical procedure, a catheter 122 and a guidewire 124 areshown displayed within or relative to a three dimensional space. In thatexemplary image, the distal end of a catheter 122, after insertion inthe right common femoral artery a guidewire, is positioned in the rightcommon iliac artery and the guidewire 124 is shown advanced out from thetip of the catheter 122.

In the illustrated example, system 100 also includes an electronics rack118. As shown in the block diagram of an overview of a robotic surgicalsystem in FIG. 3, the electronics rack 118 includes a control computer126 that performs system management and control algorithm processing.The control computer 126 is electrically coupled to the input devices atthe workstation 110 and the instrument driver 104. Control computer 126translates the desired actions input into the input device into voltagesand currents which are applied to the instrument driver 104. The blockdiagram of FIG. 4 illustrates a flow process between the input device116 to the control computer 126 to the instrument driver 104. In certainexemplary configurations, the control computer 126 may include hapticprocessing to convey electronic signals to the workstation 110, and moreparticularly to the input device 116, to produce tactile feedback to theuser. For example, the user input device 116 may provide force feedbackif the control computer 126 determines that a command for positioning(advancement, rotation, and/or steering) is inconsistent with apre-determined operational range or incompatible with informationderived from the imaging system. Other haptic feedback methodology isdiscussed below.

System components may be coupled together via a plurality of cables orother suitable connectors 120 to provide for data communication, or oneor more components may be equipped with wireless communicationcomponents to reduce or eliminate cables 120. Communication betweencomponents may also be implemented over a network or over the internet.In this manner, a surgeon or other operator may control a surgicalinstrument while being located away from or remotely from radiationsources, thereby decreasing radiation exposure. Because of the optionfor wireless or networked operation, the surgeon may even be locatedremotely from the patient in a different room or building.

The operator workstation 110 may further provide for control of theelongate instrument. As one example, shown in FIG. 5 the operatorworkstation 110 may include a set of controls having a multi-dimensionalinput device such as joystick 128 and a keyboard type input device suchas pendant 114 which may include push buttons, knobs, sliders or thelike. A typical workstation may have one or more monitors and one ormore user input devices such as a trackball, mouse, joystick, buttons,keys, sliders, thumbwheels, touch screens, stylus and the like.

In a conventional system, the elongate instrument may be controlledusing a multi-degree-of-freedom device having multiple joints andassociated encoders, such as a joystick type device. A joystick 128allows for steering of the distal tip of the guide catheter as viewed onthe computer monitor display 112, while the guidewire may be controlledusing the pendant 114. The joystick 128 may further include varioussensors to detect the position of the joystick type controller 128 andto provide signals to the controller that are interpreted as commands.In certain embodiments, the input device may have integrated hapticscapability for providing tactile feedback to the surgeon. In thatregard, the input device 116 would include motors, actuators or tensionrings, e.g., to implement haptic effects by imparting torque, detents,resistance, vibration or other forces to the input device 116.

The elongate instrument may have different configurations in differentembodiments. The elongate instrument includes an elongate body havingproximal and distal sections. The elongate instrument may be steerableor non-steerable. The elongate instrument may be tubular with a centrallumen or solid. An instrument driver 104 may be configured to controltwo elongate members in a telescopic fashion to thereby advance theelongate instrument inside a body. A variety of elongate instrumentscould be used in the robotic surgical system, depending upon thesurgical procedure and surgeon preference. Exemplary elongateinstruments include guidewires, catheters, sheaths, and guide catheters.The elongate instrument can be placed into the drive assembly prior toor during surgery; the instrument driver 104 may be configured totranslate and/or rotate the elongate instrument.

Referring now to FIG. 6, an embodiment of an instrument driver 104 isshown. The acts of advancing the first elongate instrument and thesecond elongate instrument may be performed independently orsimultaneously so that both the first and second elongate instrumentsare advanced together. An instrument driver 104 includes a sheathinstrument assembly 130 and a catheter instrument assembly 132 mountedon a top portion of instrument driver 104 and arranged in a coaxialmanner. Although instruments 130, 132 are arranged coaxially, movementof each instrument can be controlled and manipulated independently.Additional motors in instrument driver 104 may be activated to controlbending of the catheter as well as the orientation of the distal tipsthereof, including tools mounted at the distal tip.

The distal tip of the catheter instrument may be controlled byselectively operating tensioning control elements within the catheterinstrument. In one example, four opposing directional control elementswind their way to the distal end of the catheter which, when selectivelyplaced in and out of tension, cause the distal end to steerably maneuverwithin the patient. Control motors are coupled to each of thedirectional control elements so that they may be individually controlledand the steering effectuated via the operation of the motors in unison.Steerable catheters are controlled using multiple types of motion and inmultiple axes, particularly at the tip, including insertion/retraction,rotation, deflection and combinations of these motions. Details ofexemplary steerable catheters are disclosed, e.g., in U.S. Pat. No.8,021,326, the contents of which are incorporated by reference in itsentirety.

Some common elongate instruments generally are not and/or do not need tobe steerable, such as guidewires, sheaths, and guide catheters. Amicro-catheter used to pass through small body lumens is another exampleof a non-steerable instrument, where it is smaller in diameter thansteerable catheters containing driving elements. As opposed to steerablecatheters, two types of motion are generally associated with suchnon-steerable elongate instruments, i.e., axial insertion/retraction androtation.

For some embodiments of the present disclosure, a second instrumentdriver dedicated to non-steerable elongate instruments may be used. Suchdrivers need two degrees of freedom: rotation and insertion. Onevariation of an instrument driver 1100 is shown in FIG. 7. FIG. 7 showsa top view of a pair of feed rollers illustrating how linear androtation motion can be imparted to the elongate instrument. Inaccordance with the non-limiting example of this embodiment, the roboticsystem may include an instrument driver 1100 in which the elongateinstrument is a guide wire 134 and is held between first and secondrotary member 136, 138. The rotary members can be used to roboticallycontrol the insertion and retraction as well as axial rotation of anelongate instrument such as a guidewire along a longitudinal axis of theelongate instrument. To generate a linear motion for insertion andretraction, rotary members are actuated in opposite rotation directions;to generate a rotation motion, the rotary members are actuated inopposite linear directions. The drive assembly may be configured toactuate the rotary members in rotational and linear directionsindependent of one another or simultaneously. The rotary members may beactuated in the rotational and linear directions at different respectiverates. The rotary members are in the form of cylinders or feed rollersin FIG. 7 but the rotary members may include any other device suitablefor providing rotary motion including but not limited to belts.

Actuation of the one or more instrument drivers in the presentdisclosure is directed remotely at the user interface of the workstation110 using at least one input device. User input devices generallyprovide good navigation and operational functionality. For example, witha steerable catheter, a surgeon can manipulate the elongate surgicalinstrument in a plurality of directions using the appropriate inputdevice, including a joystick 128, whereby the surgeon can effect, e.g.,insertion/retraction, axial rotation, and multi-directional tipdeflection (radial bending). A joystick 128 with multi-dimensionalcapability allows intuitive manipulation of a physical device and isuseful for controlling objects with the same degrees of freedom as thejoystick, such as setting the end point position of the tip of asteerable catheter that can travel in three linear orthogonal axes. Ajoystick 128 can more directly relate hand motion to the expectedmovement of the elongate instrument.

Robotic systems that are designed with directional control often havemore limited capability to rotate the entire elongate instrument, sincerotation of the entire instrument is less necessary with a steerableinstrument having complete directional control at the tip. In contrast,rotation is crucial for a non-steerable instrument. When a non-steerableinstrument is attached to the robotic system, an input device such as apush button on an input pendant 114 has been used to effectuate linearand rotational motion to the non-steerable instrument. With such inputpendant 114, two buttons may be dedicated to control insertion andretraction and a second set of buttons may control clockwise andcounterclockwise rotation. In this example for inputting one degree offreedom, holding down of a single first button may cause a motion in apre-defined direction at a pre-defined speed and release of the buttonwould cease motion.

Guidewires and other non-steerable elongate instruments can be difficultto position and to control due to their relatively minimal navigationdegrees of freedom, the need to impart the motion to the proximal end ofthe elongate instrument, and the tortuous pathways through whichoperators navigate them. Controlling velocity and controllingcoordinated insertion and rotation, however, can be challenging with apush button that is inherently binary. Controlling coordinated motion ofthe catheter 122 and guide wire 124 using the joystick type controller128 in combination with the pendant device 114 may also be difficult foroperators to perform. For example, to perform a spiraling motion forbreaking friction in wire control, the operator may be required tosimultaneously push two buttons. Thus such systems may lack theprecision desired by operators of the robotic catheter system forperforming MIS operations. Furthermore, at times the assumed motion ofthe instrument does not match the actual motion of the instrument at theproximal end. One reason for this is the presence of unanticipated orun-modeled constraints imposed by the patient's anatomy.

The present disclosure addresses these issues and the need for an inputdevice that is useful to accurately control both steerable andnon-steerable elongate instruments. An exemplary embodiment of thepresent disclosure uses a three dimensional input device such as ajoystick 128 to guide both the steerable and non-steerable elongateinstruments, whereby the different functionality necessary for thedifferent elongate instruments can be selected at the workstation 110.One exemplary configuration of the present disclosure has two modes ofoperation where the first mode utilizes conventional joystick-typecontrol of a steerable catheter. The second operational mode restrictsthe three dimensional input device to two dimensions. Thus, according toan embodiment of the present disclosure, a sub-set of the workspace canbe selected to control the manipulator/driver of the non-steerableelongate instrument such as the guidewire or non-steerable catheter.

Referring now to FIG. 8A, a standard workspace for a three dimensionaljoystick 128 is a three dimensional sphere, whereby shaft 142 isrotatably coupled to base 144 and configured for motion within a threedimensional workspace 140. As seen in FIG. 8B, the present disclosurecontemplates that the workspace of the input device may be selectivelyrestricted to a single plane 146, representing two degrees of freedom,in a second operational mode. In an exemplary configuration, the forwardmovement of a joystick 128 would correspond to insertion and thebackward movement would correspond to retraction of the elongateinstrument. In such an embodiment, side to side motion would correlateto rotation in the clockwise or counterclockwise direction. Thus,according to this exemplary embodiment, the joystick 128 is used toselectively control objects with fewer degrees of freedom than the inputdevice while also controlling a non-linear axis. Hence, this exemplaryembodiment incorporates the ability to select between two differentoperational modes on an input device typically used for controllingobjects in the X, Y, Z orthogonal planes, where the second operationmode is restricted to the X and Y orthogonal plane for one linearmovement (insert/retract) and one non-linear movement (roll). Theimmediate advantage for the linear aspect of the embodiment is theintuitive position-based control provided to the user; another advantageis the ability to include velocity and acceleration.

Further, by superimposing control of the two axes into one input device116, complex motions can be commanded with greater ease. Additionally,the joystick 128, as an exemplary input device 116, restores certainkinesthetic information. The present disclosure further contemplatesadditional embodiments to improve the user's ability to control anelongate surgical instrument like guidewire 124 using a threedimensional joystick 128. With the workspace of the joystick 128selectively restricted to only a single plane 146, the joystick 128 isamenable to be further enhanced to operate in an intuitive manner fornon-steerable elongate instruments, according to additional embodimentsdiscussed below. Robotic input devices that emulate manual proceduresare desirable to achieve precise control and physician ease of use. Easeof use can translate to fewer and more confident movement, leading tosafer, quicker and more cost effective surgeries, and may enable moredifficult procedures.

Because the catheter is maneuvered by control motors, a computer, andthe like, the surgeon lacks tactile feedback to get an intuitive senseof the location of the distal end of the catheter. Haptic or tactilefeedback can either restore proprioception associated with a manualsurgical procedure or even augment the information that would beconveyed to the surgeon in a manual procedure. Thus, the presentdisclosure not only enables the proprioceptive feedback channel but alsohas the capability through mapping and haptics to enhance a user'sability to garner information that is available from the controlcomputer as a result of the robotic process. For example, to performcertain desired applications, such as, e.g., instinctive driving anddriving in a fluoroscopy view or a pre-operative model, the presentembodiment can include information to the physician through tactilefeedback implemented via haptic processing by the control computer. Thecontrol computer determines the haptic signal and implements the hapticeffect by sending haptic signals or commands to one or more motors orother actuators used in the input device. Haptic feedback can includeresistance, detents, active push or pull, vibration, and the like. Thehaptic signals can be varied as function of the position and movement ofthe input device.

In some exemplary embodiments, the mapping of the workspace can befurther modified to enhance dexterity and tactile and visual feedback.Keeping with the example that motion in the forward and backwarddirections could translate to insertion and retraction of the guidewireand motion in the left and right directions could translate to rollclockwise and roll counterclockwise, this plane can be emphasized orconveyed to the user as a virtual floor and/or ceiling. The user canvisualize the position on the virtual floor/ceiling as well as visualizethe constraint on the user's ability to manipulate the controlleroutside of the plane. The image of the actual movement of the elongateinstrument can be juxtaposed to the virtual plane to provide additionalvisual feedback. Mapping schemes can be further overlaid to providevisual feedback concerning joystick positioning and the correspondingpositioning of the elongate instrument. The mapping scheme would also beuseful for control computer to generate the haptic signals to the inputdevice.

Haptic feedback is also envisioned in certain exemplary embodiments. Forexample, the joystick can also be used to apply gradually increasingforce (or sudden increases) in a certain direction to limit the velocityor acceleration of a user's input such that it does not exceed apre-determined safe value, or a hardware limitation. In addition thekinesthetic channel allowed for by the use of this multidimensionaljoystick can be used to provide additional information to the operator,thereby improving the operability of a joystick for two dimensionalmovement. For example, when the limits of rotation of either axis hasbeen reached, a left or right virtual wall can be erected to prevent theoperator from attempting to travel any further in that direction andinforming them of this limitation in a non-visual way.

Further, in one exemplary arrangement, the virtual work space caninclude multiple zones and tactile feedback to address the differentneeds associated with navigating the elongate instrument through theanatomy of a patient in contrast to robotically manipulating a guidesheath and inner catheter at a work site. As seen in the illustration ofa mapping in FIG. 9, different zones, positioned at the front and backboundary of the workspace, can be designed for different types ofcontrol. These zones can be separated by virtual detent forces that needto be overcome to cross from one zone to the next. This is useful forwhen making long insertion motions and eliminates the need to re-clutchmultiple times. The presence of a virtual detent 150 requires the userto make a full stop before moving onto a velocity control zone 148. Thisallows a velocity controller to linearly scale the velocity based on theamount of penetration into the velocity control zone, effectivelystarting at zero velocity at the detent location 150 and reaching themaximum allowable velocity at the outer end of the velocity control zone148. In this manner, once the shaft of the joystick is pushed forwardover the detent 150, the velocity control zone 148 is active. Once thewire is located at the general target site, precise motion control isdesirable and the shaft of the joystick can be position in the precisioncontrol 149.

In one optional aspect of the embodiment, the velocity control zone maybe expanded to the middle of the position control zone when retracting,so that the user can switch back to position control when he or shereaches the middle of the workspace. In the embodiment as depicted inFIG. 9, only linear insertion/retraction is subject to the dual zoneswhereas a single rotation zone extends to the boundary of the workspace.Of course, control of the axis does not need to be limited to purelyposition or velocity based.

Another optional embodiment would include scaling techniques to enablefiner control for the operator. In this non-limiting example, inputsfurther away from the origin (clutch-point) may be scaled to correspondto greater motion. In that embodiment, the driving mode would be suchthat for large motions, large sweeps of the input device should be madebut frequent re-clutching would be performed to maintain commands closeto the origin for finer control. Another embodiment is to use theinstantaneous velocity and/or acceleration of the user's input todynamically scale the amount of output motion, with the assumption thata faster (more aggressive) motion indicates that greater motion isdesired.

In one exemplary embodiment, tactile feedback is added to either guidemotion so as to eliminate roll being unintentionally commanded or toprovide a sensory communication to the surgeon of the amount of rollbeing imparted to the input device. Haptic forces could be applied tothe input device in the form of a centering force to assist the user inmoving predominantly in only one axis without precluding simultaneousmotion. This force could be overcome by the user (such as a detent) toenable simultaneous motion in both axis. In addition, the magnitude ofthe resistive force could be scaled based on the velocity of the input.One technique for this embodiment would contemplate force impedimentsfor faster, larger motions to be restricted but slower, finer motionwould be impediment-free so that the user is free to combine distinctinput modes such as insert and roll in that approach. One advantage ofthis embodiment is the assistance of insertion and retraction withoutaccidental rolling of the guidewire.

As illustrated in FIG. 10, one exemplary aspect of such an embodimentcould take the form of a virtual corrugated floor 160 having peaks 152and valleys 154. In guiding the input device, the input device wouldfreely move in one axis (that could represent linear motion) but faceincreasing resistance to movement in the second axis (that couldrepresent rotation) until reaching the peak 152. Peak 152 represents adetent which provides feedback to the surgeon that a predeterminedangular rotation was effected. The centering force in the insert/retractdirection could be applied keeping the motion in the valley 154 tofurther assist the surgeon in effecting linear motion without unintendedroll. The force or heights of the corrugation peaks should be setsufficiently low to retain the ability to perform simultaneous motions.This optimizes the ability to direct insertion without unintendedrolling of the guidewire but without entirely removing the ability tocommand a spiral insertion when desired.

Accordingly, in this embodiment, the corrugations allow a user to “feel”the amount of roll has been commanded and provide haptic feedback on theamount of roll commanded. In a manual surgery, the surgeon has a tactilesense of the amount that he or she has rolled the proximal end of theguidewire, and thus this embodiment would restore a sense of the amountof rotation imparted robotically to better mimic the tactile feedback ofa manual surgery. This is important to avoid potential guidewire whip atthe distal end of the guidewire, which occurs when rotation at theproximal end of the guidewire has not translated to the distal end dueto friction as a result of tissue contact or the bending of theguidewire within the anatomy of the patient. Once the friction isovercome by the build-up of torque in the guidewire, the distal end ofthe guidewire may whip around. By knowing the amount of rotationimparted on the guidewire—e.g., crossing four detents each representinga 90 degree turn would be a full rotation—the surgeon can recognizebased on guide wire tip movement if wind-up is occurring and thatfurther rolling of the guide wire should be avoided.

This embodiment could be implemented with many variations. For example,the frequency (corresponding to angular rotation) and amplitude(corresponding to peak height) of the virtual corrugated floor can bepre-determined or selectable by the surgeon. Similarly, the magnitude ofthe resistance to motion or detents for haptic feedback can be varied.The proportionality of the haptic feedback may be user selectable.Further, the frequency and amplitude could be variable. For oneexemplary embodiment, the amount of force to overcome the detent andreach the next valley could be increased every periodic detent to give asecond signal the surgeon of the amount of rotation. One example wouldbe that the periodic detent of greater resistance force would representone full turn or selectable number of turns. Another exemplaryembodiment would gradually increase the height of the peaks as morerotation was imparted on the guidewire.

In one exemplary embodiment, the user could select between movement on aplane with or without corrugations. A user could select from multiplelevels/floors to enable different types of centering forces. Selectioncould be made in a conventional fashion via switches, touchscreens,buttons or the like. Alternatively, switching could be made along theZ-axis which is not utilized for motion commands. The embodiment couldbe configured to permit the user to lift the controller upwards to popinto a second floor with corrugations a flat floor without anycorrugation, a floor with corrugations running in opposite directions,or another scheme.

In another embodiment, similar to the virtual corrugated floor, avirtual ruler can be deployed to restrict user motion in a singledirection, effectively decoupling the two modes of operation. In thecontemplated embodiment, the virtual ruler would not be in active stateall the time but only deployed on a need basis. For example, the virtualruler would allow the user to perform insertion without being affectedby inadvertent roll motion and can be used in conjunction with thevirtual corrugated floor, which provides valuable kinesthetic feedbackregarding the amount of roll.

The use of haptic forces in the form of resistance or detents isapplicable to many types of input devices. For example, a pen-type inputdevice is contemplated within the present disclosure, an example ofwhich is shown in FIG. 11. The pen device 165 for manipulating theposition and orientation of an elongate instrument includes an innermember 161 and an outer member 162. The inner member 161, asillustrated, has a generally cylindrical shape that defines an axis 163.The outer member 162 is coaxially disposed on the inner member 161 andis configured to rotate about and move along the axis 163. This movementof the outer member 162 relative to the inner member 161 may be detectedand signals the user's desired operation of the elongate instrument.Specifically, rotating the outer member 162 about the axis 163 mayindicate the desire to rotate the elongate instrument whereas moving theouter member 162 along the axis 1163 may indicate the desire to advanceor retract the elongate instrument relative to the patient. Similar tothe haptic feedback provided to the joystick type input device, therotation control and/or the insertion control can be selected from avariety of options including but not limited to unrestricted movement,increasing resistance, and periodic movement limitations in the form ofincreased resistance or detents. Further, in an exemplary embodiment,detents could be employed to represent a predetermined angular rotationof the rotation controller. Another variation would permit thepredetermined angular rotation to be selectable by the user.

For certain variations of the instrument driver, the capability ofmeasuring external force applied to the distal end of the elongateinstrument, e.g., a guidewire, may be desirable. Thus, if a distal tipof the guidewire makes contact with tissue, the user could be made awareof the force being applied to the tissue where the instrument driverincludes a variation force sensing during insert/retract and rollactuation. In yet another embodiment, the haptics capability may beimplemented in conjunction with catheter position using Fiber OpticShape Sensing and Localization (FOSSL), which is a technology that cansense the shape of a flexible body such as a catheter during a surgicalprocedure to permit visualization of the catheter in the patient'sanatomy.

The different driving modes and/or different combinations of drivingmodes are advantageous in allowing an elongate instrument (catheter,sheath, guidewire) to access any part of the vasculature. In someembodiments, the system described herein may be used to treat thoracicaneurysm, thoracoabdominal aortic aneurysm, abdominal aortic aneurysm,isolated common iliac aneurysm, visceral arteries aneurysm, or othertypes of aneurysm. Embodiments of the system described herein may beused to deliver any substance into a patient's body, including but notlimited to contrast (e.g., for viewing under fluoroscope), drug,medication, blood, etc. In further embodiments, the system describedherein may be used to access renal artery for treating hypertension,uterine artery fibroids, atherosclerosis, and any peripheral arterydisease. In still further embodiments, the system described herein maybe used to access any part of a digestive system ore respiratory system.

Operator workstation 112 may include a computer or a computer readablestorage medium. In general, computing systems and/or devices, such asthe processor and the user input device, may employ any of a number ofcomputer operating systems, including, but by no means limited to,versions and/or varieties of the Microsoft Windows® operating system,the Unix operating system (e.g., the Solaris® operating systemdistributed by Oracle Corporation of Redwood Shores, Calif.), the AIXUNIX operating system distributed by International Business Machines ofArmonk, N.Y., the Linux operating system, the Mac OS X and iOS operatingsystems distributed by Apple Inc. of Cupertino, Calif., and the Androidoperating system developed by the Open Handset Alliance.

Computing devices generally include computer-executable instructions,where the instructions may be executable by one or more computingdevices such as those listed above. Computer-executable instructions maybe compiled or interpreted from computer programs created using avariety of programming languages and/or technologies, including, withoutlimitation, and either alone or in combination, Java™, C, C++, VisualBasic, Java Script, Perl, etc. In general, a processor (e.g., amicroprocessor) receives instructions, e.g., from a memory, acomputer-readable medium, etc., and executes these instructions, therebyperforming one or more processes, including one or more of the processesdescribed herein. Such instructions and other data may be stored andtransmitted using a variety of computer-readable media.

A computer-readable medium (also referred to as a processor-readablemedium) includes any non-transitory (e.g., tangible) medium thatparticipates in providing data (e.g., instructions) that may be read bya computer (e.g., by a processor of a computer). Such a medium may takemany forms, including, but not limited to, non-volatile media andvolatile media. Non-volatile media may include, for example, optical ormagnetic disks and other persistent memory. Volatile media may include,for example, dynamic random access memory (DRAM), which typicallyconstitutes a main memory. Such instructions may be transmitted by oneor more transmission media, including coaxial cables, copper wire andfiber optics, including the wires that comprise a system bus coupled toa processor of a computer. Common forms of computer-readable mediainclude, for example, a floppy disk, a flexible disk, hard disk,magnetic tape, any other magnetic medium, a CD-ROM, DVD, any otheroptical medium, punch cards, paper tape, any other physical medium withpatterns of holes, a RAM, a PROM, an EPROM, a FLASH-EEPROM, any othermemory chip or cartridge, or any other medium from which a computer canread.

Databases, data repositories or other data stores described herein mayinclude various kinds of mechanisms for storing, accessing, andretrieving various kinds of data, including a hierarchical database, aset of files in a file system, an application database in a proprietaryformat, a relational database management system (RDBMS), etc. Each suchdata store is generally included within a computing device employing acomputer operating system such as one of those mentioned above, and areaccessed via a network in any one or more of a variety of manners. Afile system may be accessible from a computer operating system, and mayinclude files stored in various formats. An RDBMS generally employs theStructured Query Language (SQL) in addition to a language for creating,storing, editing, and executing stored procedures, such as the PL/SQLlanguage mentioned above.

In some examples, system elements may be implemented ascomputer-readable instructions (e.g., software) on one or more computingdevices (e.g., servers, personal computers, etc.), stored on computerreadable media associated therewith (e.g., disks, memories, etc.). Acomputer program product may comprise such instructions stored oncomputer readable media for carrying out the functions described herein.

With regard to the processes, systems, methods, heuristics, etc.described herein, it should be understood that, although the steps ofsuch processes, etc. have been described as occurring according to acertain ordered sequence, such processes could be practiced with thedescribed steps performed in an order other than the order describedherein. It further should be understood that certain steps could beperformed simultaneously, that other steps could be added, or thatcertain steps described herein could be omitted. In other words, thedescriptions of processes herein are provided for the purpose ofillustrating certain embodiments, and should in no way be construed soas to limit the claims.

Accordingly, it is to be understood that the above description isintended to be illustrative and not restrictive. Many embodiments andapplications other than the examples provided would be apparent uponreading the above description. The scope should be determined, not withreference to the above description, but should instead be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled. It is anticipated andintended that future developments will occur in the technologiesdiscussed herein, and that the disclosed systems and methods will beincorporated into such future embodiments. In sum, it should beunderstood that the application is capable of modification andvariation.

All terms used in the claims are intended to be given their broadestreasonable constructions and their ordinary meanings as understood bythose knowledgeable in the technologies described herein unless anexplicit indication to the contrary in made herein. In particular, useof the singular articles such as “a,” “the,” “said,” etc. should be readto recite one or more of the indicated elements unless a claim recitesan explicit limitation to the contrary.

1. A robotic surgical system, comprising: at least one instrument driverconfigured to impart axial movement, axial rotation and articulation toan elongate instrument; at least one control computer electricallycoupled to the instrument driver to actuate the instrument driver inresponse to electronic signals; at least one input device having aninput shaft configured for movement in at least three dimensions andelectrically coupled to the control computer to provide electronicsignals to the control computer that corresponds to movement of theinput device; wherein the input device is configured to operate in atleast two operation modes, with one operation mode that permits movementof the input shaft in at least three dimensions and at least a secondoperation mode that limits the movement of the input shaft to twodimensions of movement within a plane.
 2. The robotic surgical system ofclaim 1 in which the two dimensions of movement of the second operationmode corresponds to linear movement and axial rotation of an elongateinstrument.
 3. The robotic surgical system of claim 2 further comprisinga second instrument driver configured to impart linear movement andaxial rotation to an elongate instrument when the input device is in thesecond mode of operation.
 4. The robotic surgical system of claim 2 inwhich at least one of the dimensions of movement further comprises aposition control zone and a velocity control zone and having a hapticdetent on the border between the two zones.
 5. The robotic surgicalsystem of claim 1 in which the input device is a joystick.
 6. Therobotic surgical system of claim 1, wherein the control computer isconfigured to generate haptic signals to the input device.
 7. Therobotic surgical system of claim 1, further comprising at least onemonitor to provide imaging information.
 8. The robotic surgical systemof claim 6 in which the haptic signals generated from the controlcomputer are translated into haptic signals which cause resistance onthe input shaft against movement in at least one of the two dimensionsof movement of the second operation mode.
 9. The robotic surgical systemof claim 6 in which the haptic device is configured to apply detents toimpede movement in one dimension.
 10. The robotic surgical system ofclaim 6, in which movement of the input shaft in the second dimensionhas more resistance than movement of the input shaft in the firstdimension.
 11. The robotic surgical system of claim 6, in which movementof the input shaft in the second dimension is characterized by increasedresistance until a predetermined peak resistance is reached.
 12. Therobotic surgical system of claim 11, in which the resistance againstmovement along the second dimension is repeated.
 13. The roboticsurgical system of claim 6 in which the intensity of the feedbackresistance increases until a peak resistance effecting a detent whichcan be overcome to impart a predetermined amount of rotation to anelongate instrument.
 14. The robotic surgical system of claim 13 inwhich the peak resistance corresponds to a predetermined angle ofrotation imparted to the proximal end of an elongate device.
 15. Therobotic surgical system of claim 6 wherein the algorithms implemented bycontrol computer to determine the haptic signals is mapped to acorrugated floor.
 16. The robotic surgical system of claim 2 in whichthe second operational mode uses the third dimension for switchingbetween virtual maps related to linear motion control, haptic feedbackor both.
 17. A robotic surgical system, comprising: at least one controlcomputer electrically coupled to an input device and configured toprovide haptic signals to the input device; at least one input deviceconfigured to direct movement of an elongate instrument and configuredto generate haptic effects in response to haptic signals communicatedfrom the control computer; wherein the haptic effect comprises anincreased resistive force against movement in a dimension correlated torotation.
 18. The robotic surgical system of claim 17 wherein theresistive force creates a detent that represents a predetermined aboutof angle rotation of an elongate instrument.
 19. The robotic surgicalsystem of claim 17 wherein the haptic signal is mapped to a corrugatedfloor, such that resistance is increased to a peak resistance and thendecreased to normal resistance.
 20. The robotic surgical system of claim17 wherein the output device is a joystick.
 21. The robotic surgicalsystem of claim 17 wherein the output device is a pen device.
 22. Arobotic surgical system, comprising: at least one control computerelectrically coupled to an input device and configured to provide hapticsignals to the input device; at least one input device operational intwo dimensions of movement and configured to direct movement of anelongate instrument and configured to generate haptic effects inresponse to haptic signals communicated from the control computer;wherein one of the dimensions of movement comprises two operationalzones, said operational zones relate to broad and precise linear motionof the elongate instrument and the haptic effects comprise a detent onthe border between the two zones.
 23. The robotic surgical system ofclaim 22 wherein the input device is a joystick.